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Comparison · NCT02424851-sae

Arm A (BBD) vs Arm B (BTD): serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Arm A (BBD) vs Arm B (BTD): serious adverse events. Trial comparisons, record NCT02424851-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02424851-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6880.4440.858wilson
Risk in group 20.60.3570.802wilson
Risk difference, group 1 minus group 20.0875-0.2290.384newcombe hybrid score
Risk ratio, group 1 over group 21.150.6751.94log
Odds ratio, group 1 over group 21.470.3356.43log
Number needed to harm, for one more participant with a serious adverse event on Arm A (BBD) than on Arm B (BTD)11.4from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm A (BBD)
Bortezomib, Bendamustine and Dexamethasone~Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).~\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
1116EG000
Group 2Arm B (BTD)
Thalidomide, Bendamustine and Dexamethasone~Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)~Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
915EG001

Harm

What it counts
Total, serious adverse events
Time frame
4 years, 2 months.

Source ClinicalTrials.gov

Trial

Title
Optimising Renal Outcome in Myeloma Renal Failure
NCT number
NCT02424851
Phases
PHASE2
Conditions
Multiple Myeloma, Chronic Kidney Disease
Interventions
Bortezomib, Thalidomide, Bendamustine, Dexamethasone
Lead sponsor
Oxford University Hospitals NHS Trust
Results first posted
2022-01-27

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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